Four 2×2 Factorial Trials of Smartphone CBT to Reduce Subthreshold Depression and to Prevent New Depressive Episodes Among Adults in the Community-RESiLIENT Trial (Resilience Enhancement with Smartphone in LIving ENvironmenTs): a Master Protocol

Overview

Journal BMJ Open

Specialty General Medicine

Date 2023 Feb 24

PMID 36828653

Authors

Toshi A Furukawa

Aran Tajika

Masatsugu Sakata

Yan Luo

Rie Toyomoto

Masaru Horikoshi

Tatsuo Akechi

Norito Kawakami

Takeo Nakayama

Naoki Kondo

Shingo Fukuma

Hisashi Noma

Helen Christensen

Ronald C Kessler

Pim Cuijpers

James M S Wason

Affiliations

Soon will be listed here.

Abstract

Introduction: The health burden due to depression is ever increasing in the world. Prevention is a key to reducing this burden. Guided internet cognitive-behavioural therapies (iCBT) appear promising but there is room for improvement because we do not yet know which of various iCBT skills are more efficacious than others, and for whom. In addition, there has been no platform for iCBT that can accommodate ongoing evolution of internet technologies.

Methods And Analysis: Based on our decade-long experiences in developing smartphone CBT apps and examining them in randomised controlled trials, we have developed the Resilience Training App Version 2. This app now covers five CBT skills: cognitive restructuring, behavioural activation, problem-solving, assertion training and behaviour therapy for insomnia. The current study is designed as a master protocol including four 2×2 factorial trials using this app (1) to elucidate specific efficacies of each CBT skill, (2) to identify participants' characteristics that enable matching between skills and individuals, and (3) to allow future inclusion of new skills. We will recruit 3520 participants with subthreshold depression and ca 1700 participants without subthreshold depression, to examine the short-term efficacies of CBT skills to reduce depressive symptoms in the former and to explore the long-term efficacies in preventing depression in the total sample. The primary outcome for the short-term efficacies is the change in depressive symptoms as measured with the Patient Health Questionnaire-9 at week 6, and that for the long-term efficacies is the incidence of major depressive episodes as assessed by the computerised Composite International Diagnostic Interview by week 50.

Ethics And Dissemination: The trial has been approved by the Ethics Committee of Kyoto University Graduate School of Medicine (C1556).

Trial Registration Number: UMIN000047124.

References

Inoue A, Kawakami N, Tsuno K, Tomioka K, Nakanishi M . Organizational justice and major depressive episodes in Japanese employees: a cross-sectional study. J Occup Health. 2013; 55(2):47-55. DOI: 10.1539/joh.12-0131-oa. View

McAlister F, Straus S, Sackett D, Altman D . Analysis and reporting of factorial trials: a systematic review. JAMA. 2003; 289(19):2545-53. DOI: 10.1001/jama.289.19.2545. View

Furukawa T, Shinohara K, Sahker E, Karyotaki E, Miguel C, Ciharova M . Initial treatment choices to achieve sustained response in major depression: a systematic review and network meta-analysis. World Psychiatry. 2021; 20(3):387-396. PMC: 8429344. DOI: 10.1002/wps.20906. View

Boutron I, Altman D, Moher D, Schulz K, Ravaud P . CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017; 167(1):40-47. DOI: 10.7326/M17-0046. View

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011; 20(10):1727-36. PMC: 3220807. DOI: 10.1007/s11136-011-9903-x. View

Mantani A, Kato T, Furukawa T, Horikoshi M, Imai H, Hiroe T . Smartphone Cognitive Behavioral Therapy as an Adjunct to Pharmacotherapy for Refractory Depression: Randomized Controlled Trial. J Med Internet Res. 2017; 19(11):e373. PMC: 5695656. DOI: 10.2196/jmir.8602. View

Fiellin D, Reid M, OConnor P . Screening for alcohol problems in primary care: a systematic review. Arch Intern Med. 2000; 160(13):1977-89. DOI: 10.1001/archinte.160.13.1977. View

Muramatsu K, Miyaoka H, Kamijima K, Muramatsu Y, Tanaka Y, Hosaka M . Performance of the Japanese version of the Patient Health Questionnaire-9 (J-PHQ-9) for depression in primary care. Gen Hosp Psychiatry. 2018; 52:64-69. DOI: 10.1016/j.genhosppsych.2018.03.007. View

Sakata M, Toyomoto R, Yoshida K, Luo Y, Nakagami Y, Uwatoko T . Components of smartphone cognitive-behavioural therapy for subthreshold depression among 1093 university students: a factorial trial. Evid Based Ment Health. 2022; 25(e1):e18-e25. PMC: 9811098. DOI: 10.1136/ebmental-2022-300455. View

10.

Bush B, Shaw S, Cleary P, Delbanco T, Aronson M . Screening for alcohol abuse using the CAGE questionnaire. Am J Med. 1987; 82(2):231-5. DOI: 10.1016/0002-9343(87)90061-1. View

11.

Chan A, Tetzlaff J, Altman D, Laupacis A, Gotzsche P, Krleza-Jeric K . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013; 158(3):200-7. PMC: 5114123. DOI: 10.7326/0003-4819-158-3-201302050-00583. View

12.

Kroenke K, Spitzer R, Williams J . The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001; 16(9):606-13. PMC: 1495268. DOI: 10.1046/j.1525-1497.2001.016009606.x. View

13.

Shimoda H, Inoue A, Tsuno K, Kawakami N . One-year test-retest reliability of a Japanese web-based version of the WHO Composite International Diagnostic Interview (CIDI) for major depression in a working population. Int J Methods Psychiatr Res. 2014; 24(3):204-12. PMC: 6878242. DOI: 10.1002/mpr.1437. View

14.

Spitzer R, Kroenke K, Williams J, Lowe B . A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006; 166(10):1092-7. DOI: 10.1001/archinte.166.10.1092. View

15.

Furukawa T, Suganuma A, Ostinelli E, Andersson G, Beevers C, Shumake J . Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant data. Lancet Psychiatry. 2021; 8(6):500-511. PMC: 8838916. DOI: 10.1016/S2215-0366(21)00077-8. View

16.

Bartram D, Sinclair J, Baldwin D . Further validation of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) in the UK veterinary profession: Rasch analysis. Qual Life Res. 2012; 22(2):379-91. DOI: 10.1007/s11136-012-0144-4. View

17.

Peters L, Andrews G . Procedural validity of the computerized version of the Composite International Diagnostic Interview (CIDI-Auto) in the anxiety disorders. Psychol Med. 1995; 25(6):1269-80. DOI: 10.1017/s0033291700033237. View

18.

Mundt J, Marks I, Shear M, Greist J . The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002; 180:461-4. DOI: 10.1192/bjp.180.5.461. View

19.

Bone C, Simmonds-Buckley M, Thwaites R, Sandford D, Merzhvynska M, Rubel J . Dynamic prediction of psychological treatment outcomes: development and validation of a prediction model using routinely collected symptom data. Lancet Digit Health. 2021; 3(4):e231-e240. DOI: 10.1016/S2589-7500(21)00018-2. View

20.

Mdege N, Brabyn S, Hewitt C, Richardson R, Torgerson D . The 2 × 2 cluster randomized controlled factorial trial design is mainly used for efficiency and to explore intervention interactions: a systematic review. J Clin Epidemiol. 2014; 67(10):1083-92. DOI: 10.1016/j.jclinepi.2014.06.004. View